Devices, systems and methods for enclosing an anatomical opening

ABSTRACT

The present technology is directed generally to devices, systems, and methods for enclosing anatomical openings. In one example, an aneurysm device is endovascularly deliverable to a site proximate to an arterial aneurysm. The aneurysm device comprises a closure structure having a distal-facing aspect configured to at least partially occlude the aneurysm and a proximal-facing aspect configured to arch over lumina of an artery. The closure structure can include a plurality of struts forming support arms and anchoring arms. The device further includes a supplemental stabilizer connected to the closure structure and configured to reside in the artery and press outward against a luminal wall thereof. A barrier can span at least a portion of the distal-facing aspect of the closure structure and be configured to further occlude a neck of the aneurysm. The closure structure can be configured to restrict and/or divert flow to or from the aneurysm.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.15/496,657, filed on Apr. 25, 2017 and entitled DEVICES, SYSTEMS ANDMETHODS FOR ENCLOSING AN ANATOMICAL OPENING, which in turn is adivisional of U.S. patent application Ser. No. 14/808,343, now U.S. Pat.No. 9,636,117, filed on Jul. 24, 2015 and entitled DEVICES, SYSTEMS ANDMETHODS FOR ENCLOSING AN ANATOMICAL OPENING, which in turn is adivisional of U.S. patent application Ser. No. 13/646,602, now U.S. Pat.No. 9,119,625, filed on Oct. 5, 2012 and entitled DEVICES, SYSTEMS ANDMETHODS FOR ENCLOSING AN ANATOMICAL OPENING, which claims the benefit ofU.S. Provisional Application No. 61/543,785, filed on Oct. 5, 2011 andentitled DEVICES, SYSTEMS AND METHODS FOR ENCLOSING AN ANATOMICALOPENING, all of which are incorporated herein by reference in theirentireties.

TECHNICAL FIELD

The present technology relates to implantable therapeutic devices andmethods for endovascular placement of devices at a target site, such asan opening at a neck of an aneurysm.

BACKGROUND

Many of the currently available surgical approaches for closing openingsand repairing defects in anatomical lumens and tissues (e.g., bloodvessels), septal defects, and other types of anatomical irregularitiesand defects are highly invasive. Surgical methods for clipping brainaneurysms, for example, require opening the skull, cutting or removingoverlying brain tissue, clipping and repairing the aneurysm from outsidethe blood vessel, and then reassembling tissue and closing the skull.Surgical techniques for repairing septal defects are also highlyinvasive. The risks related to anesthesia, bleeding, and infectionassociated with these types of procedures are high, and tissue that isaffected during the procedure may or may not survive and continuefunctioning.

Minimally invasive surgical techniques have been developed to placeocclusive devices within or across an opening or cavity in the body,such as in the vasculature, spinal column, fallopian tubes, bile ducts,bronchial and other air passageways, and the like. In general, animplantable device is guided along a delivery catheter and through adistal opening of the catheter using a pusher or delivery wire to deploythe device at a target site in the vasculature. Once the occlusivedevice has been deployed at the target site, it is detached from thepusher mechanism without disturbing placement of the occlusive device ordamaging surrounding structures.

Minimally invasive techniques are also highly desirable for treatinganeurysms. In general, the minimally invasive therapeutic objective isto prevent material that collects or forms in the cavity from enteringthe bloodstream and to prevent blood from entering and collecting in theaneurysm. This is often accomplished by introducing various materialsand devices into the aneurysm. One class of embolic agents includesinjectable fluids or suspensions, such as microfibrillar collagen,various polymeric beads, and polyvinylalcohol foam. Polymeric agents mayalso be cross-linked to extend their stability at the vascular site.These agents are typically deposited at a target site in the vasculatureusing a catheter to form a solid space-filling mass. Although some ofthese agents provide for excellent short-term occlusion, many arethought to allow vessel recanalization due to their absorption into theblood. Other materials, such as hog hair and suspensions of metalparticles, have also been proposed and used to promote occlusion ofaneurysms. Polymer resins, such as cyanoacrylates, are also employed asinjectable vaso-occlusive materials. These resins are typically mixedwith a radiopaque contrast material or are made radiopaque by theaddition of a tantalum powder. Accurate and timely placement of thesemixtures is crucial and very difficult because it is difficult orimpossible to control them once they have been placed in the blood flow.

Implantable vaso-occlusive metallic structures are also well known andcommonly used. Many conventional vaso-occlusive devices have helicalcoils constructed from a shape memory material or noble metal that formsa desired coil configuration upon exiting the distal end of a deliverycatheter. The function of the coil is to fill the space formed by ananatomical defect and to facilitate the formation of an embolus with theassociated allied tissue. Multiple coils of the same or differentstructures may be implanted serially in a single aneurysm or othervessel defect during a procedure. Implantable framework structures arealso used in an attempt to stabilize the wall of the aneurysm or defectprior to insertion of filling material such as coils.

Techniques for delivering conventional metallic vaso-occlusive devicesto a target site generally involve a delivery catheter and a detachmentmechanism that detaches the devices, such as a coil, from a deliverymechanism after placement at the target site. For example, amicrocatheter can be initially steered through the delivery catheterinto or adjacent to the entrance of an aneurysm either with or without asteerable guidewire. If a guidewire is used, it is then withdrawn fromthe microcatheter lumen and replaced by the implantable vaso-occlusivecoil. The vaso-occlusive coil is advanced through and out of themicrocatheter and thus deposited within the aneurysm or other vesselabnormality. It is crucial to accurately implant such vaso-occlusivedevices within the internal volume of a cavity and to maintain thedevice within the internal volume of the aneurysm. Migration orprojection of a vaso-occlusive device from the cavity may interfere withblood flow or nearby physiological structures and poses a serious healthrisk.

In addition to the difficulties of delivering implantable occlusiondevices, some types of aneurysms are challenging to treat because ofstructural features of the aneurysm or because of particularities of thesite. Wide-neck aneurysms, for example, are known to present particulardifficulty in the placement and retention of vaso-occlusive coils.Aneurysms at sites of vascular bifurcation are another example where theanatomical structure poses challenges to methods and devices that areeffective in treating the typical sidewall aneurysms.

In view of such challenges, implanting conventional embolic coils, otherstructures, or materials in the internal space of an aneurysm has notbeen an entirely satisfactory surgical approach. The placement proceduremay be arduous and lengthy because it often requires implanting multipledevices, such as coils, serially in the internal space of the aneurysm.Higher risks of complication from such sources as anesthesia, bleeding,thromboembolic events, procedural stroke, and infection are associatedwith such longer procedures. Moreover, because placement of structuresin the internal space of an aneurysm does not generally completelyocclude the opening, recanalization of the original aneurysm may occur,and debris and occlusive material may escape from within the aneurysm tocreate a risk of stroke or vessel blockage. Blood may also flow into theaneurysm and other blood vessel irregularities after the placement ofembolic devices, which may increase the risks of complication andfurther enlargement of the aneurysm.

Despite the numerous conventional devices and systems available forimplanting embolic materials in an aneurysm and for occludingphysiological defects using minimally invasive techniques, theseprocedures remain risky and rarely restore the physiological structureto its normal, healthy condition. It is also challenging to positionconventional implantable devices during deployment, prevent shifting ormigration of such devices after deployment, and preserve blood flow inneighboring vessels following after deployment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an isometric view of an aneurysm device configured inaccordance with an embodiment of the technology.

FIG. 1B is an isometric view of a closure structure portion of theaneurysm device of FIG. 1A.

FIG. 1C is a front view of the aneurysm device of FIG. 1A implanted atan aneurysm and configured in accordance with embodiments of thetechnology.

FIG. 2 is an isometric view of a closure structure portion of ananeurysm device configured in accordance with embodiments of thetechnology.

FIG. 3 is an isometric view of an aneurysm device configured inaccordance with embodiments of the technology.

FIG. 4 is an isometric view of an aneurysm device configured inaccordance with embodiments of the technology.

FIG. 5 is an isometric view of a closure structure portion of ananeurysm device configured in accordance with embodiments of thetechnology.

FIGS. 6A and 6B are isometric and front views, respectively, of aclosure structure portion of an aneurysm device configured in accordancewith embodiments of the technology.

FIG. 6C is a front view of the closure structure portion of FIGS. 6A and6B implanted at an aneurysm in accordance with embodiments of thetechnology.

FIG. 7A is a front view of a closure structure portion of an aneurysmdevice configured in accordance with embodiments of the technology.

FIGS. 7B-7D are isometric views of the closure structure portion of FIG.7A configured in accordance with embodiments of the technology.

FIG. 8A is an isometric view of an aneurysm device configured inaccordance with embodiments of the technology.

FIGS. 8B and 8C are front views of the aneurysm device of FIG. 8A beingplaced at an aneurysm in accordance with embodiments of the technology.

FIG. 9 is an isometric view of a closure structure portion of ananeurysm device configured in accordance with embodiments of thetechnology.

FIGS. 10A and 10B are isometric and front views, respectively, of aclosure structure portion of an aneurysm device configured in accordancewith embodiments of the technology.

FIGS. 11A and 11B are isometric and top views, respectively, of aclosure structure portion of an aneurysm device configured in accordancewith embodiments of the technology.

FIGS. 12A and 12B are isometric and side views, respectively, of ananeurysm device configured in accordance with embodiments of thetechnology.

FIGS. 13A and 13B are top views an aneurysm device in an unassembledconfiguration in accordance with embodiments of the technology.

DETAILED DESCRIPTION

The present disclosure describes implantable therapeutic devices andmethods for endovascular placement of devices at a target site, such asan opening at a neck of an aneurysm. In several embodiments, atherapeutic aneurysm device is endovascularly deliverable to a siteproximate to an arterial aneurysm. The aneurysm device comprises aclosure structure having a distal-facing aspect configured to at leastpartially occlude the aneurysm and a proximal-facing aspect configuredto arch over lumina of an artery. The device further includes asupplemental stabilizer connected to the closure structure andconfigured to reside in the artery and press outward against a luminalwall thereof in some embodiments, the device can also include a barrierspanning at least a portion of the distal-facing aspect of the closurestructure and configured to further occlude a neck of the aneurysm.

The following description provides specific details for a thoroughunderstanding of, and enabling description for, embodiments of thedisclosure. Well-known structures, systems, and methods often associatedwith aneurysm treatment have not been shown or described in detail toavoid unnecessarily obscuring the description of the various embodimentsof the disclosure. In addition, those of ordinary skill in the relevantart will understand that additional embodiments may be practiced withoutseveral of the details described below.

FIG. 1A is an isometric view of an aneurysm device 100 having a closurestructure 110 and a support or supplemental stabilizer 120 configured inaccordance with embodiments of the technology. FIG. 1B is an isometricview of the closure structure 110. Referring to FIGS. 1A and 1Btogether, the closure structure 110 can be a frame, scaffold, or otherstructure that at least partially occludes the neck of an aneurysm toprevent embolic coils or other coagulative material within the aneurysmfrom escaping into the bloodstream. The closure structure 110 comprisesa plurality of scaffold struts or supports 130 (identified individuallyas struts 130 a-130 f). The struts 130 are joined together at corners115, 116, and 117. The corners 115, 116, and 117 can be longitudinalcorners that define the proximal end of the closure structure 110 thatextends along the longitudinal axis L-L. The struts 130 can furtherinclude lateral corners 125, 126, and 127 defining a lateral aspect ofthe closure structure 110 that extends along the lateral axis T-T. Theembodiment of the closure structure 110 illustrated in FIGS. 1A and 1Bis generally symmetrical with respect to the centerlines of both thelongitudinal L-L and the lateral T-T axes, but in other embodiments theclosure structure 110 may have an asymmetrical configuration withrespect to either or both of the longitudinal and lateral axes. Althoughthe corners 125, 126, and 127 are illustrated as being rounded orlooped, other embodiments of the corners may have a more pointedprofile, a more complex curve, or other angular configurations. Thestruts 130 may be formed integrally with one another from a sheet ofmaterial, or separate struts may be formed and bonded together at thecorners.

The closure structure 110 can define a distal framework portion, and thesupplemental stabilizer 120 can define a proximal framework portion.Each of these portions can have one or more pairs of struts 130 (e.g.,strut 130 a is “paired” with strut 1300. In some embodiments, the struts130 can curve inwardly toward the longitudinal axis L-L of the aneurysmdevice 100. The outline of the struts 130 is typically that of aquadrilateral form. In some embodiments, the struts 130 can have arhombus-like configuration or diamond shape. In several embodiments, thestruts 130 can bend to provide a tailored fit to a particularvasculature. In some embodiments, the struts 130 can bend or flexiblymove independently of one another. For example, strut 130 c may bendfurther into an aneurysm body than strut 130 b. This independentadjustability can provide a customized fit to the particular contours ofa given aneurysm, creating a more secure hold.

As discussed above, the struts 130 can be symmetrical (e.g., the samelength along orthogonal axes) or asymmetrical in which one side of therhombus-like structure can have an axis longer than the other side.Although many closure structures 110 described below have quadrilateralforms, the closure structures 110 are not limited to these shapes inthat the distal-facing aspect of the distal framework portion may haveother shapes, such as polygons or polygonal curvilinear shapes. Inseveral embodiments, the rhombus-like supports 130 are concentric with acenter at the longitudinal axis L-L of the aneurysm device 100. Thelateral apices of the closure structure 102 are disposed at opposingends of the lateral axis T-T of the distal framework portion. The twoportions of the distal framework portion opposite each other across thelongitudinal axis L-L may define lateral leaves of the distal frameworkportion.

In various embodiments, the closure structure 110 can be used incombination with the supplemental stabilizer 120 or independently fromthe supplemental stabilizer 120 at a neck of an aneurysm. Thelaterally-extending branches of the closure structure 110 and thesupplemental stabilizer 120 hold the curved portion of the closurestructure 110 at the neck of the aneurysm. However, in some embodiments,using the closure structure 110 independently of the supplementalstabilizer 120 can decrease the amount of contact the aneurysm device100 has with a patient's vasculature. For example, in some embodiments,the closure structure 110 can be used independently of the supplementalstabilizer in the treatment of a ruptured aneurysm. In some embodiments,the supplemental stabilizer 120 can be used during placement of theclosure structure 110, but then removed.

FIG. 1C is a front view of the aneurysm device of FIG. 1A in a deployedconfiguration and implanted at an aneurysm in accordance withembodiments of the technology. In the deployed configuration, theclosure structure 110 has a distally projecting arch defined by a curvedsection of the distal framework portion. The supplemental stabilizer 120extends proximally from the closure structure 110 at an angle relativeto a lateral axis. A proximal-facing aspect of the arch of the closurestructure 110 extends over the lumina of the bifurcating arteries. Adistal-facing aspect of the arch of the closure structure 110 generallypresses against the luminal surfaces of the bifurcating arteries. Thedistal-facing aspect of the closure structure 110 is configured tosubstantially align with or otherwise conform to the neck of theaneurysm by forming a curved surface that compatibly aligns with orengages the neck and the surrounding wall of the side branch vessels. Insome embodiments, the distal-facing aspect has a complex curve, such asa hyperbolic paraboloid (e.g., a generally saddle-shaped form). In theillustrated embodiment, the hyperbolic paraboloid comprises a generallyY-shaped curve with a depressed central portion. The supplementalstabilizer 120 can have struts that extend down into the parent arteryand press outwardly against the luminal surface thereof.

The distal-facing aspect or back of the proximal-facing surfacegenerally aligns against the luminal surfaces of the bifurcatingarteries, the sides of the arch extending down into the parent arteryand aligned against the luminal surface thereof. The proximal face ofthe arch is generally and substantially transverse (perpendicular ororthogonal) to the lateral axis of the proximal framework. The archspans unobtrusively over the lumina of the bifurcating arteries, formingno incursion into the vascular flow path. More particularly, the archcan be a non-enclosed opening or hole, but instead a structure entirelyopen in the proximal direction. In further embodiments, as will bediscussed in more detail below, the closure structure 110 can include acover or barrier portion spanning across one or more distal frameworkstruts and configured to occlude the neck of the aneurysm.

FIG. 2 is an isometric view of a closure structure 210 of an aneurysmdevice configured in accordance with embodiments of the technology. Theclosure structure 210 has several features generally similar to theclosure structure 110 described above with reference to FIGS. 1A-1C. Theclosure structure 210 further includes a barrier 240 spanning across adistal-facing aspect.

In the illustrated embodiment, the closure structure 210 includesperimeter struts 232 and curved inner arms 230 that meet the perimeterstruts 232 at longitudinal corner points 217. The closure structure 210is capable of temporary or permanent attachment to a supplementalstabilizer (such as the supplemental stabilizer 120 described above withreference to FIG. 1A) at the corner points 217. The inner arms 232extend distally from the corner point 217, along a longitudinal midlineL-L of the closure structure 210, and curve distally and laterally to anoff-centered position. The inner arms 232 therefore allow the closurestructure 210 and the barrier 240 to keep and maintain a shape in adeployed configuration and to fold up or compress in a spiral mannerduring delivery and/or removal.

The barrier 240 can be formed with or permanently or removably attachedto the perimeter and inner arms 232, 230. The barrier 240 can compriseone or more permeable or semi-permeable membranes, covers, sheets,panels, mesh, or other structures that form an occlusive orsemi-occlusive covering that (a) restricts, diverts, redirects, orinhibits vascular flow into the cavity of the aneurysm and/or (b)prevents materials from escaping the cavity. In this aspect, devices andmethods of the described technology may provide repair andreconstruction of a blood vessel or a junction of blood vessels byplacement and retention of the closure structure 210 across the neck ofthe aneurysm that diverts blood flow away from the aneurysm. Followingplacement and deployment, the barrier 240 may substantially cover theaneurysm neck and the closure structure 210 can form a structure thatsubstantially conforms to the tissue surrounding the aneurysm and/or theneighboring vessel walls. The highly conforming fit generally restoresthe vascular anatomical neighborhood to a normal or more normalconfiguration, thereby supporting a normal vascular flow pattern andoverall function. In the illustrated embodiments, the barrier 240includes a barrier aperture 242 configured to provide access to theaneurysm (e.g., access for a catheter, access to deliver coils, etc.) Aswill be described in further detail below, the barrier 240 can comprisea single sheet or panel, or can comprise a plurality of sheets or panelslayered and/or otherwise arranged on the device to achieve a desiredbarrier pattern and/or structure.

FIG. 3 is an isometric view of an aneurysm device 300 configured inaccordance with embodiments of the technology. Generally similar to theaneurysm devices described above, the aneurysm device 300 includes aclosure structure 310 and a supplemental stabilizer 320. The closurestructure 310 comprises a plurality of nested, rhombus-shaped pairs ofstruts 330 a-330 c (collectively struts, 330). A barrier 340 spans thestruts 330 and includes a central hole or slit 342 at a central portionof the closure structure 310, within the innermost set of struts 330 a.

FIG. 4 is an isometric view of an aneurysm device 400 configured inaccordance with embodiments of the technology. Generally similar to theaneurysm device 300 described above with reference to FIG. 3, theaneurysm device 400 includes a closure structure 410 and a supplementalstabilizer 420. The closure structure 410 comprises a plurality struts430 a-430 c (collectively struts, 430) forming nested rhombus shapes. Inthis embodiment, however, a barrier 440 spans only the space between theinnermost struts 330 a and the middle struts 330 b.

The illustrated configurations are merely representative of the numerousarrangements the struts 430 and barrier 440 could take. For example,there could be more or fewer than three sets of nested struts 430, andthe barrier 440 could cover more or fewer areas or parts of areasbetween the struts 430. In some embodiments, the degree of barriercoverage across the struts can be selected based on a desired degree ofocclusion, type or characteristics of the aneurysm, and/or desiredaccess to the body of the aneurysm.

FIG. 5 is an isometric view of a closure structure portion 510 of ananeurysm device configured in accordance with embodiments of thetechnology. The closure structure 510 has several features generallysimilar to the closure structure 210 described above with reference toFIG. 2. For example, the closure structure 510 has a barrier 540spanning across perimeter struts 532 and curved inner arms 530. thebarrier 540 includes an optional access aperture 542.

The closure structure 510 further includes flexible anchor legs 552distally coupled to the perimeter struts 530. While two legs 552 areshown descending from the illustrated side of the closure structure 510,there can be more or fewer legs 552, of the same or differentdimensions, in further embodiments of the technology. The anchor legs552 can provide pivotable movement (or shock absorption) between theclosure structure 610 and a supplemental stabilizer, such as thesupplemental stabilizer 120 described above with reference to FIG. 1A.The anchor legs 552 can comprise springs, hinges, or other movable orflexible structures that would allow movement of the closure structure510 relative to a supplemental stabilizer.

FIGS. 6A and 6B are isometric and front views, respectively, of aclosure structure 610 having several features generally similar to theclosure structures described above. FIG. 6C is a front view of theclosure structure 610 at an aneurysm in accordance with embodiments ofthe technology. Referring to FIGS. 6A-6C together, the closure structure610 includes a barrier 640 spanning distal arms 630. The closurestructure 610 further includes proximal arms 660 coupled to the distalarms 630 via a midline strut 662. In the illustrated embodiment, themidline strut 662 extends distally from a distal arm junction point 617.The barrier 640 can include an aperture 642 therein.

In several embodiments, at least one of the distal arms 630 or proximalarms 660 are curved or parabolic shaped to better conform to the shapeof the aneurysm or the vasculature to provide the desired degree ofaneurysm occlusion and device stability. For example, in the illustratedembodiment, the distal arms 630 extend distally but have a lateral,proximally-dipping curve, while the proximal arms 660 have anapproximately 180-degree distal curve before projecting laterally. Asbest shown in FIG. 6C, the distal arms 630 can be placed within theaneurysm and can conform against the aneurysm wall, while the proximalarms 660 can conform against the luminal wall outside of the aneurysm.

FIG. 7A is a front view of a closure structure 710 configured inaccordance with embodiments of the technology. FIGS. 7B-7D are isometricviews of the closure structure 710. Referring to FIGS. 7A to 7Dtogether, the closure structure 710 includes multiple sets of nested,generally triangular-shaped baffles or panels 730 a-730 c (collectivelypanels 730). Each panel 730 comprises a strut framework and sheets orpanels of barrier 740 a-740 c (collectively barrier 740). Pairs ofpanels 730 join at junctions 717 a-717 c on a central stem.

The panels 730 can be individually covered by the barrier 740, or pairsof struts (e.g., forming a V-shape) can be covered. One or more panels730 can include an opening or hole 742. For example, in the illustratedembodiment, the closure structure 710 includes a central hole 742 thatextends longitudinally through each pair of adjacent panels 730, therebyproviding access from a proximal side of the closure structure 710 tothe interior of the aneurysm. While the panels 730 are discussed astriangles, in further embodiments the panels 730 can be shaped asrectangles, circles, squares, or other polygonal or curved shapes. Thepanels 730 can laterally overlap and can be used to control, contain,and/or divert flow. The panels 730 can function as baffles that canpivotably bend or otherwise move relative to one another to adjust froman open state to a closed state. In various embodiments of use, one ormore of the panels 730 can be inside the aneurysm while other panels 730can be outside the aneurysm. In further embodiments, all of the panels730 can be inside or outside the aneurysm.

FIG. 8A is an isometric view of an aneurysm device 800 configured inaccordance with embodiments of the technology. The aneurysm device 800includes a closure structure 810 and a supplemental stabilizer 820. Theclosure structure 810 includes one or more rhombus-shaped sets of struts830 a, 830 b (collectively struts 830), generally similar to the closurestructures described above. The closure structure 810 further includesdistally-extending anchor arms 838. In the illustrated embodiment, thestruts 830 are curved distally and laterally, in some embodimentsextending laterally beyond the anchor arms 838.

FIGS. 8B and 8C are front views of the aneurysm device of FIG. 8A beingplaced at an aneurysm in accordance with embodiments of the technology.The struts 830 are configured to curve against the exterior neck of theaneurysm. In further embodiments, one or more of the struts 830 can beplaced within the aneurysm. The anchor struts 838 can be located withinthe side walls of the aneurysm and can provide improvedfit/conformability to the aneurysm neck. As shown in FIG. 8C, in someembodiments, the supplemental stabilizer 820 can be removed upon stableplacement of the closure structure 810 or can be not used at all.

FIG. 9 is an isometric view of a closure structure portion 910 of ananeurysm device configured in accordance with further embodiments of thetechnology. Having features generally similar to several of the closurestructures described above, the closure structure 910 includes inner,middle, and outer sets of struts (numbered 930 a-930 c, respectively).In the illustrated embodiment, the inner struts 930 a expand or benddistally upward from the laterally-joined middle and outer struts 903 b,903 c. This bendability provides a niche between the inner 930 a andmiddle 930 b struts. In use, the niche can be used to clip into orotherwise engage the tissue proximate to the aneurysm.

FIGS. 10A and 10B are isometric and front views, respectively, of aclosure structure 1010 configured in accordance with embodiments of thetechnology. The closure structure 1010 includes an inner set of struts1030 a and an outer set of struts 1030 b. In some embodiments, the innerset of struts 1030 a can be bent or formed in a direction offset fromthe outer set of struts 1030 b to “expand” the aneurysm device 300. Insome embodiments, the inner set of struts 1030 a can be placed in ananeurysm and the outer set of struts 330 b can be placed outside theaneurysm to anchor or stabilize the closure structure 1010 (e.g., toclip the aneurysm device into the aneurysm).

FIGS. 11A and 11B are isometric and top views, respectively, of aclosure structure 1110 configured in accordance with embodiments of thetechnology. The closure structure 1110 includes an inner set of struts1130 a and an outer set of struts 1130 b. In some embodiments, the innerset of struts 1130 a can be bent or formed in a direction offset fromthe outer set of struts 1130 b. In some embodiments, the inner set ofstruts 1130 a can be placed in an aneurysm and the outer set of struts1130 b can be placed outside the aneurysm for anchoring the closurestructure 1110.

FIGS. 12A and 12B are isometric and side views, respectively, of ananeurysm device 1200 configured in accordance with embodiments of thetechnology. The aneurysm device 1200 includes a closure structure 1210and a supplemental stabilizer 1220. The closure structure 1210 includessets of struts 1230 a-1230 c (collectively, struts 1230) arranged intriangular or rhombus configurations and extending laterally from amidline of the device 1200. As described in several embodiments above,the sets of struts 1230 can rest in or outside an aneurysm, or cansandwich or clip onto the neck of the aneurysm. In the illustratedembodiment, the supplemental stabilizer 1220 includes ring-shapedanchors 1222 extending proximally from the closure structure 1210. Theseanchors 1222 can be configured to press against vascular walls toprovide device stability without blocking blood flow.

FIGS. 13A and 13B are top views an aneurysm device 1300 in anunassembled configuration in accordance with embodiments of thetechnology. Referring to FIGS. 13A and 13B together, the aneurysm device1300 is constructed from a substantially flat substrate by cutting,etching, stamping, or otherwise forming the framework of the closurestructure 1310 and the unassembled supplemental stabilizer 1320. Inseveral embodiments, the device 1300 can be cut from a single piece ofsubstrate. For example, the closure structure 1310 (including sets ofstruts 1330 a-1330 c) and the supplemental stabilizer 1320 can beconstructed from a flat sheet of material having substantially uniformthickness. In other embodiments different regions of the sheetedmaterial can have different thicknesses corresponding to the desiredthickness for portions of the closure structure 1310 and/or thesupplemental stabilizer 1320.

The closure structure 1310 can be folded or bent into a curve along thelateral axis T-T such that the portions of the closure structure 1310associated with corners 1317 a-1317 c define paired longitudinallyaligned structures on either side and generally substantially orthogonalto the lateral axis T-T. The paired longitudinally aligned structurescan be substantially parallel to each other and define anchors that holdthe closure structure 1310 in place. The closure structure 1310 forms avertex that is resiliently bent by a total of about 180° and is biasedoutward. The outward bias of the closure structure 1310 is due to thematerials that form the closure structure, such as resilient metals oralloys including Nitinol and other shape memory metals. The outwardbiasing force is conveyed to the supplemental stabilizer 1320 from theclosure structure 1310 such that the supplemental stabilizer 1320presses outward against the lumen of a parent vessel that extends at anangle relative to the lengthwise dimension of the closure structure1310.

Radiopaque markers 1372, 1374, 1376, and 1378 or radiopaque compoundsmay be associated with certain structures or portions of the devicestructure to facilitate accurate positioning, placement and monitoringof the deployed device in the vasculature. In one embodiment, forexample, a radiopaque composition may be incorporated in the closurestructure or provided as a coating on the closure structure. Variationsin the marker geometry may be adopted to distinguish different segmentsof the device framework. For example, the proximal legs of the devicemay incorporate a marker with two dots, while the portion of the devicecloser to or in proximity to the covering may incorporate a single dot.Alternatively, different shaped markers may be used to differentiatedifferent parts of the device. Radiopaque markers may be added anywherealong the device frame or attached materials, coverings, and membranesto provide spatial location of different device components and featuresunder angiography. In several embodiments, for example, radiopaquemarkers can be added to laterally and/or longitudinally asymmetricpoints on the closure structure 1310 and/or supplemental stabilizer 1320(i.e., asymmetric with reference to the lateral axis T-T, longitudinalaxis L-L, or a center point 1370 at the intersection of the longitudinaland lateral axes). In the embodiment illustrated in FIG. 13A, markers1372, 1374, 1376, and 1378 are offset from the longitudinal axis L-L.Marker 1372 is offset by distance X4, marker 1374 is offset by distanceX2, marker 1376 is offset by distance X1, and marker 1378 is offset bydistance X3, where X1, X2, X3, and X4 are all unequal distances. Byplacing these markers asymmetrically, the markers do not overlap whenthe device is folded or compressed during placement. The device 1300 istherefore less bulky for delivery.

From the foregoing, it will be appreciated that specific embodiments ofthe disclosure have been described herein for purposes of illustration,but that various modifications may be made without deviating from thespirit and scope of the disclosure. For example, structures (such assupplemental stabilizers and/or barriers) and/or processes described inthe context of particular embodiments may be combined or eliminated inother embodiments. In particular, the aneurysm devices described abovewith reference to particular embodiments can include one or moreadditional features or components, or one or more of the featuresdescribed above can be omitted. Moreover, while advantages associatedwith certain embodiments of the disclosure have been described in thecontext of these embodiments, other embodiments may also exhibit suchadvantages, and not all embodiments need necessarily exhibit suchadvantages to fall within the scope of the disclosure.

I/We claim:
 1. An aneurysm device endovascularly deliverable through anartery to a site proximate to an aneurysm, the aneurysm devicecomprising: a central closure structure comprising a distal-facingaspect configured to at least partially occlude the aneurysm, aproximal-facing aspect configured to arch over lumina of an artery, andone or more distally-extending anchor arms; and a supplementalstabilizer connected to the closure structure, the supplementalstabilizer configured to reside in the artery and press outward againsta luminal wall thereof; wherein the distal-facing aspect comprises aplurality of laterally opposing supports aligned longitudinally with theartery, the supports comprising sets of struts.
 2. The aneurysm deviceof claim 1, wherein the distal-facing aspect of the closure structureforms a curved surface.
 3. The aneurysm device of claim 2, wherein thecurved surface comprises a hyperbolic paraboloid form.
 4. The aneurysmdevice of claim 1, wherein the struts of the individual opposingsupports are coupled together at a common stem.
 5. The aneurysm deviceof claim 1, wherein at least one of the individual opposing supports ispivotably moveable relative to another opposing support.
 6. The aneurysmdevice of claim 1, wherein the opposing supports are alignedlongitudinally with respect to the artery and extend laterally beyondthe anchor arms.
 7. The aneurysm device of claim 1, wherein the closurestructure and supplemental stabilizer comprise a longitudinal axis ofthe device.
 8. The aneurysm device of claim 1, wherein, when the closurestructure is deployed to at least partially occlude the aneurysm, atleast one of the distally-extending anchor arms is configured to beinside the aneurysm.
 9. The aneurysm device of claim 1, wherein thedistally-extending anchor arms comprise struts which are coupledproximal of the aneurysm at common stems.
 10. The aneurysm device ofclaim 1, wherein the supplemental stabilizer is configured to bedetachable from the closure structure.
 11. The aneurysm device of claim9, wherein the struts of the individual opposing supports are curveddistally and laterally away from the longitudinal axis.
 12. A device foroccluding an aneurysm, the device comprising: a central closurestructure comprising a plurality of laterally opposing support armsconfigured to at least partially occlude the aneurysm, a proximal-facingaspect configured to arch over lumina of an artery, and one or moredistally-extending anchor arms; and a supplemental stabilizer connectedto the closure structure, the supplemental stabilizer configured to bedetachable from the closure structure; wherein the laterally opposingsupport arms, comprise sets of struts which form a general rhombusshape; and wherein the distally-extending anchor arms comprise strutswhich are coupled proximal of the aneurysm at a longitudinal apices. 13.The device of claim 12, wherein the supplemental stabilizer isconfigured to reside in the artery and press outward against a luminalwall thereof.
 14. The device of claim 12, wherein the opposing supportarms are aligned longitudinally with respect to the artery.
 15. Thedevice of claim 12, wherein the struts of the individual opposingsupport arms form a junction at common longitudinal apices.
 16. Thedevice of claim 12, wherein one or more of the individual opposingsupport arms are configured to be inside the aneurysm.
 17. The device ofclaim 12, wherein at least one of the distally-extending anchor arms isconfigured to anchor inside the aneurysm.
 18. The device of claim 12,wherein the sets of struts which form the rhombus shape formlongitudinal junctions joining the struts at longitudinal apices andlateral junctions joining the struts at apices of a lateral axis. 19.The device of claim 18, wherein at least one of the lateral junctionsextends laterally beyond at least one of the one or moredistally-extending anchor arms.
 20. The device of claim 12, wherein eachof the individual opposing support arms are pivotably moveable relativeto another opposing support arm.